Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
19
Countries
2
Sites
5
Systemic Lupus Erythematosus
Key facts
- Sponsor
- Glaxosmithkline Research & Development Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- completed 6 May 2025
- Decision date (initial)
- 2025-02-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-510340-20-00
- ClinicalTrials.gov
- NCT06413511
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Systemic Lupus Erythematosus
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Glaxosmithkline Research & Development Limited
- Sponsor organisation
- Glaxosmithkline Research & Development Limited
- Address
- G S K House, 980 Great West Road 980 Great West Road
- City
- Brentford
- Postcode
- TW8 9GS
- Country
- United Kingdom
Scientific contact point
- Organisation
- Glaxosmithkline Research & Development Limited
- Contact name
- EU GSK Clinical Trials Call Center
Public contact point
- Organisation
- Glaxosmithkline Research & Development Limited
- Contact name
- EU GSK Clinical Trials Call Center
Locations
2 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 3 | 3 |
| Spain | Ended | 3 | 2 |
| Rest of world
United States
|
— | 13 | — |
Investigational sites
Assistance Publique Hopitaux De Paris
Hospital Pitie Salpetriere Service de Medecine maladies auto-immunes et systemique, 47 Boulevard De L Hopital, 75651, Paris Cedex 13
Centre Hospitalier Universitaire De Bordeaux
Hospital Saint Andre Service de medecine interne et immunologie clinique, 1 Rue Jean Burguet, 33000, Bordeaux
Centre Hospitalier Universitaire De Toulouse
Hospital Rangueil Service de medecine interne et immunologie clinique, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-24 | Spain | Acceptable 2024-10-28
|
2024-10-28 |
| 2 | SUBSEQUENT ADDITION OF MSC | APP-2 | 2024-11-26 | Acceptable 2024-10-28
|
2025-02-26 |